ABSTRACT
Except for companies that outsource all data management to contract research organization (CROs) or electronic data capture (EDC) vendors, all data management groups use computer systems to carry out their data management tasks. These are either the large and specialized applications known as clinical data management (CDM) systems or they are the web-based EDC systems that are deployed directly to investigator sites. CDM systems were developed when the majority of trials were conducted on paper and continue to provide features to support those. As EDC for data collection has moved to the forefront, these CDM systems have integrated with or added on EDC front ends so that they can support both kinds of trials. In this chapter, we will focus on the characteristics of CDM systems generally. EDC front ends and stand-alone EDC applications are discussed in the next chapter.
